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Idylla instrument
Official notice
30 Dec 2024
Last checked
30 Dec 2024
An official Health Canada notice concerns Idylla instrument. Biocartis received a complaint on several Idylla MSI test false positive results generated on a single instrument. As part of the investigation, Biocartis conducted a review of the Idylla MSI test performance in the field. A review of all connected runs from 2019 to date identified suspected false positive Idylla MSI test runs obtained by customers in Germany, Italy, Poland, Estonia, Cyprus, and Thailand. Recall start date: December 9, 2024 Published 2024-12-30.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76770
Official notice
2024-12-30
The hazard
The hazard
Biocartis received a complaint on several Idylla MSI test false positive results generated on a single instrument. As part of the investigation, Biocartis conducted a review of the Idylla MSI test performance in the field. A review of all connected runs from 2019 to date identified suspected false positive Idylla MSI test runs obtained by customers in Germany, Italy, Poland, Estonia, Cyprus, and Thailand. Recall start date: December 9, 2024
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Biocartis, Idylla Instrument.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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